Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01942135
First received: September 10, 2013
Last updated: July 13, 2016
Last verified: July 2016
Results First Received: December 3, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Metastatic Breast Cancer
Interventions: Drug: Palbociclib
Drug: Fulvestrant
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted at 144 sites in 17 countries that randomized 521 participants. Eligible participants were to have histologically or cytologically proven diagnosis of adenocarcinoma of the breast with evidence of recurrent (local or metastatic) disease.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study consisted of a screening visit within 28 days before randomization, an active treatment phase, divided in cycles of 28 days each, and a post-treatment follow-up period during which survival and new anti-cancer therapy information was collected every 3 months for the first 9 months, then every 6 months from the last dose of study drug.

Reporting Groups
  Description
Palbociclib + Fulvestrant Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
Placebo + Fulvestrant Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.

Participant Flow:   Overall Study
    Palbociclib + Fulvestrant     Placebo + Fulvestrant  
STARTED     347     174  
COMPLETED     0     0  
NOT COMPLETED     347     174  
Adverse Event                 9                 3  
Global deterioration of health status                 8                 3  
Randomized Not Treated                 2                 2  
Death                 0                 1  
ObjectiveProgression+Progressive Disease                 85                 87  
Participant Refused toContinue Treatment                 1                 1  
Withdrawal by Subject                 4                 2  
Ongoing at date of cut-off (05 Dec 2014)                 238                 75  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Palbociclib + Fulvestrant Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
Placebo + Fulvestrant Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
Total Total of all reporting groups

Baseline Measures
    Palbociclib + Fulvestrant     Placebo + Fulvestrant     Total  
Number of Participants  
[units: participants]
  347     174     521  
Age  
[units: Years]
Mean (Standard Deviation)
  56.9  (11.7)     56.8  (10.4)     56.9  (11.3)  
Gender  
[units: Participants]
     
Female     347     174     521  
Male     0     0     0  



  Outcome Measures
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1.  Primary:   Progression-Free Survival (PFS) as Assessed by the Investigator   [ Time Frame: From randomization date to date of first documentation of progression or death (assessed up to 12 months) ]

2.  Secondary:   Overall Survival (OS) - Number of Participants Who Died   [ Time Frame: From randomization until death (up to approximately 36 months) ]

3.  Secondary:   Objective Response (OR)   [ Time Frame: From randomization until end of treatment (assessed up to 12 months) ]

4.  Secondary:   Duration of Response (DR)   [ Time Frame: From randomization until end of treatment (assessed up to 12 months) ]

5.  Secondary:   Clinical Benefit Response (CBR)   [ Time Frame: From randomization until end of treatment (assessed up to 12 months) ]

6.  Secondary:   Survival Probabilities at Months 12, 24 and 36   [ Time Frame: From randomization until death (assessed up to 36 months) ]

7.  Secondary:   Observed Plasma Trough Concentration (Ctrough) for Palbociclib   [ Time Frame: Cycle 1/Day 15 and Cycle 2/Day 15 ]

8.  Secondary:   Ctrough for Fulvestrant   [ Time Frame: Cycles 2/Day 1 and Cycle 3/Day 1 ]

9.  Secondary:   Ctrough for Goserelin   [ Time Frame: Cycles 2/ Day 1 and Cycle 3/ Day 1 ]

10.  Secondary:   Change From Baseline Between Treatment Comparison in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scale Scores   [ Time Frame: From Cycle 1 to 14, as of 05 December 2014. ]

11.  Secondary:   Change From Baseline Between Treatment Comparison in EORTC QLQ-C30 Symptom Scale Scores   [ Time Frame: From Cycle 1 to 14, as of 05 December 2014. ]

12.  Secondary:   Change From Baseline Between Treatment Comparison in European Organization for Research and Treatment of Cancer Breast Cancer Module (EORTC QLQ BR23) Functional Scale Scores   [ Time Frame: From Cycle 1 to 14, as of 05 December 2014. ]

13.  Secondary:   Change From Baseline Between Treatment Comparison in EORTC QLQ BR23 Symptom Scale Scores   [ Time Frame: From Cycle 1 to 14, as of 05 December 2014. ]

14.  Secondary:   Change From Baseline Between Treatment Comparison in EuroQoL 5D (EQ-5D)- Health Index Scores   [ Time Frame: From Cycle 1 to 14, as of 05 December 2014. ]

15.  Secondary:   Change From Baseline Between Treatment Comparison in EQ-5D Visual Analog Scale (VAS) Scores Scale   [ Time Frame: From Cycle 1 to 14, as of 05 December 2014. ]

16.  Secondary:   Time to Deterioration (TTD)   [ Time Frame: Baseline, Day 1 of Cycles 2 to 4, Day 1 of every alternate cycle after that until the end of treatment ]

17.  Secondary:   Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs; All Causalities)   [ Time Frame: From the signing of the informed consent until 28 days after the last dose of study medication up to 14 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01942135     History of Changes
Other Study ID Numbers: A5481023
2013-002580-26 ( EudraCT Number )
Study First Received: September 10, 2013
Results First Received: December 3, 2015
Last Updated: July 13, 2016
Health Authority: United States: Food and Drug Administration